If microchip systems that act like organs are ever going to really change preclinical drug development, it’s going to happen one experiment—and Big Pharma adopter—at a time. Emulate is trying to take on that challenge, and today it’s gotten its first supporter, Johnson & Johnson.
Cambridge, MA-based Emulate, the “organ-on-a-chip” startup spun out of Harvard University’s Wyss Institute last year, is applying its technology—thumbnail-sized microchips that mimic how organs behave—to three of J&J’s preclinical drug programs. J&J, through its Janssen Biotech unit, is using the chips try to get a better read on how these drug candidates would affect human beings: Will they cause blood clots, or liver problems—the type of safety problems that have doomed various drugs in the past?
“It really will help us in the near term begin to make decisions about which things we should advance and spend more time on,” says Michelle Browner, J&J’s senior director of platform innovation and partnership management, and a Roche executive for nearly two decades before that.
Financial terms of the deal aren’t being disclosed; Emulate president and chief scientific officer Geraldine Hamilton would only say it enables the company to start generating revenue now, and get a piece of potential product sales down the road. She added that Emulate will announce at least three more similar partnerships this year, with other pharma players and companies in other industries like cosmetics and chemical-safety testing.
These deals are, of course, small steps in a long and difficult journey for Emulate. It’s trying to convince drugmakers to change their R&D practices, and add microchips to other methods they typically use to get early look at how safe their products are.
The need is significant, however. While preclinical testing of experimental drugs in petri dishes, and later animals, is the industry standard, even the most convincing data from these tests aren’t guaranteed to work in humans. That unpredictability often leads to clinical failures, many of which happen after millions of dollars have already been spent on their development.
Emulate is one of a fast-growing group of players trying to change the paradigm with a technology designed to make preclinical testing more predictive of how drugs will perform in humans, and ultimately improve odds of success in clinical trials. Initially, Emulate hopes to complement current preclinical research methods; perhaps, one day, it will gather enough evidence that regulators will take notice and accept data from chip studies as a replacement, reducing the need for animal studies. That is particularly tall order that’ll likely take years to become a reality.
“It’s obviously a very long goal, especially given the rate [at] which regulatory agencies change their practice, and what their requirements are, and rightly so,” Browner says.
There’s also competition. Aside from other companies in the organ-on-chip space (CN Bio Innovations, a spin-out of the University of Oxford; Nortis, of Seattle; Tara Biosystems, of New York; and Netherlands-based Mimetas, to name a few), innovators are using other methods. Organovo Holdings, for example, uses 3-D printing techiques. Charlottesville, VA-based HemoShear Therapeutics has a way to see how blood flow affects cells in culture. There are plenty of others, each vying for the best way to help drugmakers get more reliable preclinical results. (Check out these features from Nature and The Economist for more.)
Emulate is one of the more high-profile efforts to join the fray. It was incubated within the Wyss Institute for around four years, based on the work of its founder and a pioneer of the organ-on-a-chip field, Donald Ingber. Emulate raised around $40 million in grant money from the Defense Advanced Research Projects Agency (DARPA), and then spun out of the Wyss last July with a $12 million Series A and a team of about 30.
As I wrote last year, Emulate claims that its chips provide a more detailed and representative look at biological function than those of its rivals—they include cells, blood flow, and use mechanical forces to mimic the function of an organ. Its lung chip, for instance, is infused with human lung cells and capillaries, and contracts and expands, mimicking breathing. Emulate has also been using the DARPA money in an effort to link several of its chips together to create a system that mimics the whole human body.
Emulate’s plan is to forge a string of partnerships with pharma companies and iterate its own technology based on their needs. Browner says, for instance, that the lung chip intrigued J&J, and that has led the two companies to collaborate on an effort to recreate the conditions of thrombosis—blood clots—in a new microchip with Emulate’s technology. The results of that work will be submitted to a peer-reviewed publication this year, Hamilton says.
That’s important to J&J, because it’s trying to understand how and why, for instance, certain cancer drug candidates can cause blood clots, and perhaps figure out how to avoid clots with future drugs. Emulate, meanwhile, gains the intellectual property for any new products that emerge from the collaborative work, meaning it could then sell these “thrombosis chips”—or whatever the next product is that the two create—to other companies too.
Hamilton knows that for Emulate to make the type of broad impact it’s envisioning—to have technology that becomes a standard of drug R&D and, as Browner says, “sits on our lab benches”—the J&J deal must be just one of many examples of industry players using its chips.
“The FDA understands the need for improved regulatory sciences, but [it] needs to see widespread adoption, and the generation of data from many different groups,” she says. “Long-term relationships with the end user—pharma partners, partners in the cosmetics industry going forward—are going to be really important.”